BREXIT – What are the consequences for authorisation procedures?

Dr. Petra Kauch

At the moment, there is considerable uncertainty in numerous industries regarding the potential consequences of Brexit. The issue of approval procedures in the biogenetic field cannot be excluded from this.

Currently, the evaluation of plant protection products is carried out according to uniform European standards. In the so-called ZVU procedure, the initial authorization of a product from another member state is recognized, thus ensuring homogeneity at the European level. Whether this procedure can continue to be applied after Brexit is currently unclear. On March 6, 2019, at the instigation of the EU Commission, the Federal Office of Consumer Protection and Food Safety (BVL) announced that mutual recognition applications can no longer be granted after Brexit, even if the applications were submitted before Brexit. With the UK's exit, ZVU approval is no longer possible. This would result in distortions of competition and a reduction in the availability of these products on both sides. The Braunschweig Administrative Court, in contrast, is pursuing a different strategy. Various plant protection product manufacturers had filed applications for interim measures, which are currently pending before the Braunschweig Administrative Court. Following the applicants' arguments, the Administrative Court considers the legal opinion of the EU Commission and the BVL to be unlawful. A marketing authorisation granted before Brexit or an application submitted before that date must be assessed on a fully EU basis according to the ZVU procedure. This is because at the time the marketing authorisation was granted or the application was submitted, Great Britain was still a member of the EU.

However, both views leave open an assessment of the situation after Brexit. Therefore, it remains to be seen whether applications for approval can be successfully submitted after Brexit. Currently, however, there are still discrepancies regarding the Brexit consequences in the area of ​​approval that require clarification, leading to considerable uncertainty among those affected. It is advisable to clarify this situation as soon as possible.

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